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Implementation of a transcutaneous bilirubinometer in a newborn nursery : A randomized Controlled Trial

(2017)Boer, L. den (Lieve)

Objective: The aim of this study is to provide quantitative data on the reduction of blood sampling when using transcutaneous bilirubinometry to assess hyperbilirubinemia in healthy jaundiced newborns.
Study-design: In a randomized controlled trial in jaundiced infants (≥36 weeks gestational age) in a Dutch newborn nursery ward, the need for total serum bilirubin (TSB) measurement to determine hyperbilirubinemia was assessed by either a transcutaneous bilirubin (TcB) measurement (JM-103) (intervention group) or visual assessment of jaundice (control group). When TcB was within 50μmol/L below the threshold for phototherapy on the bilirubin nomogram, a TSB was obtained.
Results: A total of 254 neonates were randomized to either the intervention group (n=127) or the control group (n = 127). In the intervention group 43 neonates (33.9%) needed one or more TSB measurements taken versus 85 neonates (66.9%) in the control group (difference 33.0; 95% CI 21.4 to 44.6, P = <0.001). There was a significant reduction of 46.9% in blood sampling for TSB assays in the intervention group compared to the control group (0.50±0.80 vs 0.94±0.83, difference -0.44 (-0.64 to -0.24), P = <0.001). The number needed to treat is 3.0. There were no differences between groups in treatment, treatment duration or hospitalization.
Conclusion: Use of a transcutaneous device to assess hyperbilirubinemia significantly and safely reduced blood draws for TSB assays in 47% in healthy jaundiced near-term and term neonates in the newborn nursery.